The US Food and Drug Administration has issued warning letters to three international food companies for major breaches of federal food safety standards, with potential repercussions for US importers and retail partners sourcing tofu, non-dairy milk, and boba products.
Following inspections conducted in 2024, the FDA identified serious regulatory violations at Chongqing Tianrun Food Development Co. Ltd. in China, Baldwin Richardson Foods Pennsauken LLC in New Jersey, and Dalai Biotech Company Ltd. in Taiwan. These findings raise concerns over product integrity and public safety, particularly around low-acid canned foods (LACF) and acidified food products prone to botulism and microbial contamination if mishandled.
In China, Chongqing Tianrun was found to have shipped tofu-based LACF products to the US without registering as a Food Canning Establishment and without approved thermal processing procedures. The facility lacked qualified personnel and failed to monitor critical production parameters such as fill weight, temperature, and sealing, despite consumer complaints about swollen and leaking packaging.
In the US, Baldwin Richardson Foods’ New Jersey facility was cited for failing to respond appropriately to microbiological growth detected in its Califia Toasted Coconut Almond Milk. The inspection also revealed unrecorded sterilisation metrics, unmonitored steam seals, and unresolved container integrity failures, suggesting inadequate process control in aseptic packaging.
Meanwhile, Taiwan’s Dalai Biotech shipped fruit-flavoured acidified boba pearls into the US without registering as a food processor or submitting scheduled processes. The company also lacked pH monitoring, documented recipes, and oversight by a qualified process authority, placing product safety and shelf stability in question.
The FDA has warned all three companies that failure to address these issues could lead to their products being barred from US entry under Import Alerts #99-37 or #99-38. The agency has received initial responses from each firm outlining proposed corrective measures, though documentation to verify implementation remains outstanding.
US distributors, retailers, and foodservice operators sourcing from these suppliers may face increased scrutiny and potential disruption as the FDA continues to enforce its safety protocols.